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Neurobehavioral Functioning in Pediatric Brain Tumor Patients After Proton Beam Radiation Treatment

NCT ID: NCT01180881

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-31

Study Completion Date

2018-01-01

Brief Summary

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The aim of this study is to follow up with all of the pediatric brain tumor patients who received proton beam radiation therapy at Massachusetts General Hospital (MGH) for which there is baseline neuropsychological testing in order to measure changes, if any, in neurobehavioral functioning (executive skills, emotional/behavioral functioning, and adaptive abilities) and their use of special education services at one year or more post-treatment. The investigators will also correlate neurobehavioral data with pertinent clinical information. Participation will be maximized through the use of mail-in, parental- and self-report questionnaires.

Detailed Description

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The purpose of this study is to longitudinally examine neurobehavioral functioning outcomes and use of special education services in brain tumor and CNS tumor patients treated with proton radiation at MGH. Furthermore, we seek to correlate neurobehavioral data with pertinent clinical information. We anticipate better neurobehavioral functioning to be associated with use of protons (vs. photons, as reported in the literature). We also anticipate the need and utilization of special education services to be lower in brain and CNS tumor patients treated with protons (vs. photons, as reported in the literature). Lastly, we anticipate greater neurobehavioral deficits in patients whose proton radiation treatment involved the craniospinal axis compared to those who received proton radiation to the involved field.

Conditions

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Brain Tumor Central Nervous System Neoplasms

Keywords

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Proton Radiation CNS tumors Brain Tumors Neurobehavioral functioning

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Proton Radiation Patients at MGH

Pediatric brain and central nervous system (CNS) tumor patients treated with proton beam radiation therapy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Children diagnosed with brain or CNS tumors and treated with proton radiation therapy at the MGH Francis H. Burr Proton Center since September 2002
2. Patients received baseline neurocognitive testing at MGH
3. Patients ≤25 years at the time of diagnosis
4. Tumor location in the brain or CNS
5. Radiation treatment consisted of only proton radiotherapy
6. No prior radiation exposure or chemotherapy

Exclusion Criteria

1. Patients receiving treatment with palliative intent
2. Patients who do not wish to participate
3. Patient is deceased at ≥1 year follow-up
Minimum Eligible Age

1 Year

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Margaret Pulsifer

Neuropsychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margaret B. Pulsifer, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Grieco JA, Evans CL, Yock TI, Pulsifer MB. Psychosocial and executive functioning late effects in pediatric brain tumor survivors after proton radiation. Childs Nerv Syst. 2024 Nov;40(11):3553-3561. doi: 10.1007/s00381-024-06579-2. Epub 2024 Sep 2.

Reference Type RESULT
PMID: 39222091 (View on PubMed)

Pulsifer MB, Duncanson H, Grieco J, Evans C, Tseretopoulos ID, MacDonald S, Tarbell NJ, Yock TI. Cognitive and Adaptive Outcomes After Proton Radiation for Pediatric Patients With Brain Tumors. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):391-398. doi: 10.1016/j.ijrobp.2018.05.069. Epub 2018 Jun 6.

Reference Type DERIVED
PMID: 30108004 (View on PubMed)

Other Identifiers

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2009A058394

Identifier Type: -

Identifier Source: org_study_id